Pediatric diabetes study with ProTrans in progress

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NextCell Pharma AB ("NextCell") has previously announced a clinical trial with ProTrans™ to treat children and adolescents with type 1 diabetes. The study recently started with screening of patients. Before treatment, patients are followed for about a month and the first adolescents will soon undergo treatment.

The first part of the study is a safety part (phase Ib) where all patients are treated at Akademiska university hospital. 3 patients aged 12-18 years receive treatment first and there after 3 patients aged 7-11 years. The data will then be reviewed by the Data Safety Monitoring Board, which consists of chair professor Ulf Smith, Sahlgrenska univeristy hospital and professor Mikael Rydén, Karolinska University Hospital and professor Anders Fasth, Queen Silivia Children's Hospital.

The principal investigator is professor Per-Ola Carlsson, Uppsala University and Uppsla University Hospital with co-investigators Professor Helena Elding Larsson, Skåne University Hospital and professor Johnny Ludvigsson, Linköping University Hospital.  The second part is randomised, placebo-controlled (phase II) and a total of 60 children and adolescents with type 1 diabetes should be treated, 30 with ProTrans and 30 with placebo. Recruitment will take place at the three participating hospitals in Uppsala, Linköping and Malmö.

"We estimate that we will be able to include all patients in the safety part during the spring and hopefully be able to start the recruiting of patients for the second part after the summer," says professor Carlsson.

Uppsala University Hospital is a sponsor of the study, which is funded with research grants. NextCell contributes with ProTrans and placebo in the study. In addition, the company will support the trial with logistics, documentation and expertise. No further monetary compensation is paid, i.e. NextCell will not pay for the study.

The full title of the study is: "A Double-blinded, Randomized, Parallel, Placebo-controlled trial of Wharton's Jelly-derived Allogeneic Mesenchymal Stromal Cells to treat Type I Diabetes in Children and Adolescents" (EudraCT 2020-004520-42).

For further information, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595

NextCell Pharma AB:
Cellaviva Sverige:
Cellaviva Danmark:


About NextCell Pharma AB

NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 10% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

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